Effect of palatal implants on continuous positive airway pressure and compliance. 2011

M Boyd Gillespie, and Paul E Wylie, and Teofilo Lee-Chiong, and David M Rapoport
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina 29425-5500, USA. gillesmb@musc.edu

OBJECTIVE Determine if the Pillar palatal implant system reduces continuous positive airway pressure (CPAP) pressure and improves patient compliance with CPAP therapy. METHODS Randomized, double-blind, placebo-controlled study. METHODS Four geographically dispersed tertiary sleep disorder referral centers. METHODS Subjects with mild to moderate sleep apnea dissatisfied with CPAP because of pressure-related complaints were randomized to receive Pillar implants or a sham procedure performed in double-blind fashion. Active and sham groups were compared for changes in therapeutic CPAP pressures (primary outcome) with a 90-day follow-up sleep study and CPAP compliance (secondary outcome) with a 90-day smart card report. RESULTS Twenty-six subjects were randomized to Pillar implants and 25 to a sham implant procedure. There were no differences between groups with regard to demographics and baseline parameters. Both sham and active groups had reduced mean CPAP pressure (-1.1 vs -0.5 cm H(2)O) with no difference between groups (P = .32) at 90-day follow-up. In addition, there was no difference in average daily CPAP use between groups (P = .80). Both groups experienced improvements in Epworth sleepiness scores and Functional Outcome of Sleep Questionnaire scores at 90 days with no differences between groups. The active group reported significantly higher CPAP satisfaction scores than the sham group (P = .04). CONCLUSIONS Pillar implants do not significantly reduce CPAP pressure or increase CPAP compliance compared to sham controls but may subjectively improve CPAP satisfaction. These findings do not presently support the use of Pillar implants as an adjunctive treatment to improve CPAP compliance.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010155 Palatal Expansion Technique An orthodontic method used for correcting narrow or collapsed maxillary arches and functional cross-bite. (From Jablonski's Dictionary of Dentistry), Maxillary Expansion,Palatal Expansion Technic,Expansion, Maxillary,Palatal Expansion Technics,Palatal Expansion Techniques,Technic, Palatal Expansion,Technique, Palatal Expansion
D010160 Palate, Soft A movable fold suspended from the posterior border of the hard palate. The uvula hangs from the middle of the lower border. Velum Palatinum,Soft Palate,Palates, Soft,Palatinum, Velum
D010349 Patient Compliance Voluntary cooperation of the patient in following a prescribed regimen. Client Adherence,Client Compliance,Non-Adherent Patient,Patient Adherence,Patient Cooperation,Patient Noncompliance,Patient Non-Adherence,Patient Non-Compliance,Patient Nonadherence,Therapeutic Compliance,Treatment Compliance,Adherence, Client,Adherence, Patient,Client Compliances,Compliance, Client,Compliance, Patient,Compliance, Therapeutic,Compliance, Treatment,Cooperation, Patient,Non Adherent Patient,Non-Adherence, Patient,Non-Adherent Patients,Non-Compliance, Patient,Nonadherence, Patient,Noncompliance, Patient,Patient Non Adherence,Patient Non Compliance,Patient, Non-Adherent,Therapeutic Compliances,Treatment Compliances
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D003757 Dental Implantation The grafting or inserting of a prosthetic device of alloplastic material into the oral tissue beneath the mucosal or periosteal layer or within the bone. Its purpose is to provide support and retention to a partial or complete denture. Dental Implant Therapy,Dental Prosthesis Implantation,Implantation, Dental,Implantation, Dental Prosthesis,Prosthesis Implantation, Dental,Dental Implant Therapies,Dental Prosthesis Implantations,Implant Therapy, Dental,Therapy, Dental Implant
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D005500 Follow-Up Studies Studies in which individuals or populations are followed to assess the outcome of exposures, procedures, or effects of a characteristic, e.g., occurrence of disease. Followup Studies,Follow Up Studies,Follow-Up Study,Followup Study,Studies, Follow-Up,Studies, Followup,Study, Follow-Up,Study, Followup

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